Using evidence when planning for trial recruitment: An international perspective from time-poor trialists

English version

Autoři: Heidi R. Gardner ^aff001; Shaun Treweek ^aff001; Katie Gillies ^aff001
Působiště autorů: Health Services Research Unit, Health Sciences Building, University of Aberdeen, Aberdeen, Scotland, United Kingdom ^aff001
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0226081

Souhrn

Introduction

Recruiting participants to trials is challenging. To date, research has focussed on improving recruitment once the trial is underway, rather than planning strategies to support it, e.g. developing trial information leaflets together with people like those to be recruited. We explored whether people involved with participant recruitment have explicit planning strategies; if so, how these are developed, and if not, what prevents effective planning.

Methods

Design: Individual qualitative semi-structured interviews. Data were analysed using a Framework approach, and themes linked through comparison of data within and across stakeholder groups.

Participants: 23 international trialists (UK, Canada, South Africa, Italy, the Netherlands); 11 self-identifying as ‘Designers’; those who design recruitment methods, and 12 self-identifying as ‘Recruiters’; those who recruit participants. Interviewees’ had recruitment experience spanning diverse interventions and clinical areas.

Setting: Primary, secondary and tertiary-care sites involved in trials, academic institutions, and contract research organisations supporting pharmaceutical companies.

Results

To varying degrees, respondents had prospective strategies for recruitment. These were seldom based on rigorous evidence.

When describing their recruitment planning experiences, interviewees identified a range of influences that they believe impacted success:

The timing of recruitment strategy development relative to the trial start date, and who is responsible for recruitment planning.
The methods used to develop trialists’ recruitment strategy design and implementation skills, and when these skills are gained (i.e. before the trial or throughout).
The perceived barriers and facilitators to successful recruitment planning; and how trialists modify practice when recruitment is poor.

Conclusions

Respondents from all countries considered limited time and disproportionate approvals processes as major challenges to recruitment planning. Poor planning is a mistake that trialists live with throughout the trial. The experiences of our participants suggest that effective recruitment requires strategies to increase the time for trial planning, as well as access to easily implementable evidence-based strategies.

Klíčová slova:

Canada – Clinical research design – Clinical trials – Network analysis – Qualitative studies – Research grants – Social communication – South Africa

Zdroje

1. Thoma A, Farrokhyar F, McKnight L, Bhandari M: Practical tips for surgical research: how to optimize patient recruitment. Canadian Journal of Surgery 2010, 53(3):205–210.

2. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrom M, Taskila T, et al: Strategies to improve recruitment to randomised controlled trials. Cochrane Database of Systematic Reviews 2010, (1)MR-2010.

3. Treweek S, Bevan S, Bower P, Campbell M, Christie J, Clarke M, et al: Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)? Trials [Electronic Resource] 2018, 19(139).

4. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P: Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med 2002, 251(2):156–168. doi: 10.1046/j.1365-2796.2002.00949.x 11905591

5. McCann S, Campbell M, Entwistle V: Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. Journal of Health Services & Research Policy 2013, 18(4):233–241.

6. Hughes-Morley A, Young B, Hempel RJ, Russell IT, Waheed W, Bower P: What can we learn from trial decliners about improving recruitment? Qualitative study. Trials [Electronic Resource] 2016, 17(1):494.

7. Moorcraft SY, Marriott C, Peckitt C, Cunningham D, Chau I, Starling N, et al: Patients' willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials [Electronic Resource] 2016, 17:17.

8. Carandang L, Goldsack JC, Sonnad SS: Key issues for elderly patients contemplating clinical trial participation. J Women Aging 2016, 28(5):412–417. doi: 10.1080/08952841.2015.1018046 27088345

9. Zvonareva O, Kutishenko N, Kulikov E, Martsevich S: Risks and benefits of trial participation: A qualitative study of participants' perspectives in Russia. Clinical Trials 2015, 12(6):646–653. doi: 10.1177/1740774515589592 26062594

10. Skea ZC, Treweek S, Gillies K: 'It's trying to manage the work': a qualitative evaluation of recruitment processes within a UK multicentre trial. BMJ Open 2017, 7(8):e016475. doi: 10.1136/bmjopen-2017-016475 28801422

11. Elliott D, Husbands S, Hamdy FC, Holmberg L, Donovan JL: Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches. European Urology 2017, 72(5):789–798. doi: 10.1016/j.eururo.2017.04.036 28578829

12. Bill-Axelson A, Christensson A, Carlsson M, Norlen BJ, Holmberg L: Experiences of randomization: interviews with patients and clinicians in the SPCG-IV trial. Scandinavian Journal of Urology & Nephrology 2008, 42(4):358–363.

13. Donovan JL, Paramasivan S, de Salis I, Toerien M: Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials [Electronic Resource] 2014, 15:5.

14. Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby JM: The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. J Clin Epidemiol 2014, 67(8):912–920. doi: 10.1016/j.jclinepi.2014.03.010 24811157

15. Lawton J, Kirkham J, White D, Rankin D, Cooper C, Heller S: Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial. Trials [Electronic Resource] 2015, 16:3.

16. Potter S, Mills N, Cawthorn SJ, Donovan J, Blazeby JM: Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials [Electronic Resource] 2014, 15:80.

17. Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K, et al: Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials [Electronic Resource] 2016, 17(1):283.

18. Mills N, Gaunt D, Blazeby JM, Elliott D, Husbands S, Holding P, et al: Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT RCT Recruitment Training Intervention. J Clin Epidemiol 2017 Nov 27.

19. Guest G, Bunce A, Johnson L: How Many Interviews Are Enough? An Experiment with Data Saturation and Variability. Family Health International 2006, 18(1).

20. Hennink MM, Kaiser BN, Marconi VC: Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough?. Qual Health Res 2017, 27(4):591–608. doi: 10.1177/1049732316665344 27670770

21. Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, et al: What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health 2010, 25(10):1229–1245. doi: 10.1080/08870440903194015 20204937

22. Srivastava A, Thomson SB: Framework Analysis: A Qualitative Methodology for Applied Policy Research. Journal of Administration & Governance 2009, 4(2).

23. Gale NK, Heath G, Cameron E, Rashid S, Redwood S: Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Medical Research Methodology 2013, 13:117. doi: 10.1186/1471-2288-13-117 24047204

24. Murtagh J, Dixey R, Rudolf M: A qualitative investigation into the levers and barriers to weight loss in children: opinions of obese children. Arch Dis Child 2006, 91(11):920–923. doi: 10.1136/adc.2005.085712 16820388

25. Elkington H, White P, Addington-Hall J, Higgs R, Pettinari C: The last year of life of COPD: a qualitative study of symptoms and services. Respir Med 2004, 98(5):439–445. doi: 10.1016/j.rmed.2003.11.006 15139573

26. Ayatollahi H, Bath PA, Goodacre S: Factors influencing the use of IT in the emergency department: a qualitative study. Health Informatics Journal 2010, 16(3):189–200. doi: 10.1177/1460458210377480 20889849

27. Elwyn G, Seagrove A, Thorne K, Yee Cheung W: Ethics and research governance in a multicentre study: add 150 days to your study protocol. BMJ 2005, 330:847. doi: 10.1136/bmj.330.7495.847 15817562

28. Tully J, Ninis N, Booy R, Viner R: The new system of review by multicentre research ethics committees: prospective study. BMJ 2000, 320(7243):1179–1182. doi: 10.1136/bmj.320.7243.1179 10784541

29. Ahmed AH, Nicholson KG: Delays and diversity in the practice of local research ethics committees. J Med Ethics 1996, 22(5):263–266. doi: 10.1136/jme.22.5.263 8910776

30. Lux A, Edwards S, Osborne J: Responses of local ethics committees to a study with approval from a multicentre research ethics committee. BMJ 2000, 320:1182–1183. doi: 10.1136/bmj.320.7243.1182 10784542

31. Jones A, Bamford B: The other face of research governance. BMJ 2004, 329:280–281. doi: 10.1136/bmj.329.7460.280 15284155

32. Torgerson D, Dumville J: Ethics review in research: Research governance also delays research. BMJ 2004, 328:710.

33. Galbraith N, Hawley C, De-Souza V: Research governance: research governance approval is putting people off research. BMJ 2006, 332:238.

34. Angell EL, Jackson CJ, Ashcroft RE, Bryman A, Windridge K, Dixon-Woods M: Is 'inconsistency' in research ethics committee decision-making really a problem? An empirical investigation and reflection. Clinical Ethics 2007, 2:92–99.

35. Greenhalgh T, Robert G, Macfarlane F, Bate P, O: Diffusion of innovations in service organizations: Systematic review and recommendations. The Milbank Quarterly 2004, 82(4):581–629. doi: 10.1111/j.0887-378X.2004.00325.x 15595944

36. Badgett RG, Pugh MJV: Comment on "Diffusion of innovations in service organizations: systematic review and recommendations". Milbank Q 2005, 83(1):177–178. doi: 10.1111/j.0887-378X.2005.340_1.x 15787958

37. Kameda T, Ohtsubo Y, Masanoi T: Centrality in sociocognitive networks and social influence: an illustration in a group decision-making context. J Pers Soc Psychol 1997, 73:296–309.

38. Shaw S, Boynton PM, Greenhalgh T: Research governance: where did it come from, what does it mean? J R Soc Med 2005, 98(11):496–502. doi: 10.1258/jrsm.98.11.496 16260798

39. Duley L, Gillman A, Duggan M, Belson S, Knox J, McDonald A, et al: What are the main inefficiencies in trial conduct: a survey of UKCRC registered clinical trials units in the UK. Trials [Electronic Resource] 2018, 19(1):15.

40. Honeycutt A: Maximising the employee productivity factor. International Journal of Manpower, 10(4):24–27.

41. Gorringe JAL: Initial preparations for clinical trials. In Principles and Practice of Clinical Trials. Edited by Harris EL, Fitzgerald JD. Edinburgh: Churchill Livingstone; 1970:41–46.

42. Lasagna L: The pharmaceutical revolution forty years later. Rev Farmacol Clin Exp 1984, 1:157–161.

43. Bearman JE, Loewenson RB, Gullen WH: Muench's postulates, laws, and corollaries (biometrics note No.4): Bethesda (MD), USA: Office of Biometry and Epidemiology, National Eye Institute, National Institutes of Health; 1974.

44. White D, Hind D: Projection of participant recruitment to primary care research: a qualitative study. Trials [Electronic Resource] 2015, 16:473. doi: 10.1186/s13063-015-1002-9 26482231

45. Tversky A, Kahneman D: Judgment under Uncertainty: Heuristics and Biases. Science 1974, 185(4157):1124–1131. doi: 10.1126/science.185.4157.1124 17835457

46. Kruger J: Lake Wobegon be gone! The "below-average effect" and the egocentric nature of comparative ability judgments. Journal of Personality & Social Psychology 1999, 77(2):221–232.

47. Mapstone J, Elbourne D, Roberts IG: Strategies to improve recruitment to research studies. Cochrane Database of Systematic Reviews, 2007, Issue 2. Art. No.: MR000013. doi: 10.1002/14651858.MR000013.pub3 17443634

48. Gardner HR: Making clinical trials more efficient: consolidating, communicating and improving knowledge of participant recruitment interventions. Unpublished PhD thesis, 2018, University of Aberdeen.

49. Whitham D, Turzanski J, Bradshaw L, Clarke M, Culliford L, Duley L, et al: Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study. Trials 2018, 19:557. doi: 10.1186/s13063-018-2940-9 30326967

50. Smith S, Noble H: Bias in research. Evidence Based Nursing 2014, 17(4):100–101. doi: 10.1136/eb-2014-101946 25097234

51. Hofer A, Hummer M, Huber R, Kurz M, Walch T, Fleischhacker WW: Selection bias in clinical trials with antipsychotics. J Clin Psychopharmacol 2000, 20(6):699–702. doi: 10.1097/00004714-200012000-00019 11106145

52. Clarke M, Savage G, Maguire L, McAneney H: The SWAT (study within a trial) programme; embedding trials to improve the methodological design and conduct of future research. Trials [Electronic Resource] 2015, 16 (Suppl 2):209.

53. Sahlqvist S, Song Y, Bull F, Adams F, Preston J, Ogilvie D and the iConnect consortium: Effect of questionnaire length, personalisation and reminder type on response rate to a complex postal survey: a randomised controlled trial. BMC Medical Research Methodology 2011, 11(62).

54. Harrison S, Henderson J, Alderdice F, Quigley MA: Methods to increase response rates to a population-based maternity survey: a comparison of two pilot studies. BMC Medical Research Methodology 2019, 19(65).

55. Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, et al: Methods to increase response to postal and electronic questionnaires. Cochrane Database of Systematic Reviews 2009, (3):MR000008. doi: 10.1002/14651858.MR000008.pub4 19588449

56. The Northern Ireland Hub for Trials Methodology Research: SWAT Repository Store. Available from: https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWATStore/ [last accessed 26 September 2019]

Using evidence when planning for trial recruitment: An international perspective from time-poor trialists

Souhrn

Introduction

Methods

Results

Conclusions

Klíčová slova:

Zdroje

PLOS One

INSIGHTS from European Respiratory Congress

Současné pohledy na riziko v parodontologii

Svět praktické medicíny 3/2024 (znalostní test z časopisu)

Kardiologické projevy hypereozinofilií

Střevní příprava před kolonoskopií